Special Interest Guidances/InformationDate Posted
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry – Draft Guidance30 September 2020
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential – Questions and Answers : Draft Guidance for Industry – Draft Guidance29 September 2020
Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff – Final Guidance29 September 2020
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff – Final Guidance29 September 2020
Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration Staff – Final Guidance29 September 2020
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff – Final Guidance29 September 2020
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry – Final Guidance28 September 2020
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Draft Guidance for Industry – Draft Guidance28 September 2020
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers: Draft Guidance for Industry – Draft Guidance28 September 2020
Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry – Final Guidance25 September 2020
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff – Final Guidance25 September 2020
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff – Final Guidance25 September 2020
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff– Final Guidance25 September 2020
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards- Final Guidance21 September 2020
Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry – Final Guidance15 September 2020
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry– Draft Guidance15 September 2020
Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration Staff– Final Guidance15 September 2020
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry– Final Guidance14 September 2020
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency: Guidance for Industry– Final Guidance10 September 2020
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling– Draft Guidance03 September 2020
Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” : Guidance for Industry and Food and Drug Administration Staff– Final Guidance03 September 2020
Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry– Final Guidance02 September 2020
Investigational COVID-19 Convalescent Plasma: Guidance for Industry- Final Guidance02 September 2020
Upcoming Meetings (* = New)
*Nov 6, 2020: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting
*Oct 27, 2020: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
 Oct 22, 2020: Patient Engagement Advisory Committee Meeting  
 Oct 22, 2020: Vaccines and Related Biological Products Advisory Committee  
*Oct 08-09, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting
 Oct 07, 2020: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting  
 Oct 02, 2020: Vaccines and Related Biological Products Advisory Committee  

Last updated: 01 October 2020

Back to Blog